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  2. Case report form - Wikipedia

    en.wikipedia.org/wiki/Case_report_form

    The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report forms contain data obtained during the patient's participation in the clinical trial.

  3. Electronic trial master file - Wikipedia

    en.wikipedia.org/wiki/Electronic_trial_master_file

    An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

  4. Clinical trial - Wikipedia

    en.wikipedia.org/wiki/Clinical_trial

    A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...

  5. Clinical data management - Wikipedia

    en.wikipedia.org/wiki/Clinical_data_management

    Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.

  6. Phases of clinical research - Wikipedia

    en.wikipedia.org/wiki/Phases_of_clinical_research

    Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. [1] When expressed specifically, a clinical trial phase is capitalized both in name and Roman numeral, such as "Phase I" clinical trial. [1]

  7. Glossary of clinical research - Wikipedia

    en.wikipedia.org/wiki/Glossary_of_clinical_research

    A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective.

  8. Clinical research - Wikipedia

    en.wikipedia.org/wiki/Clinical_research

    The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies (clinical trials) or observational studies on human participants.

  9. Vaccine trial - Wikipedia

    en.wikipedia.org/wiki/Vaccine_trial

    A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed. [ 1 ] A vaccine candidate drug is first identified through preclinical evaluations that could involve high throughput screening and selecting the proper antigen to invoke an immune response.

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